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Background Conversation aids can facilitate shared decision-making and improve patient-centered outcomes. However, few examples exist of sustained use of conversation aids in routine care due to numerous barriers at clinical and organizational levels. We explored factors that will promote the sustained use of two early-stage breast cancer conversation aids. We examined differences in opinions between the two conversation aids and across socioeconomic strata. Methods We nested this study within a randomized controlled trial that demonstrated the effectiveness of two early-stage breast cancer surgery conversation aids, one text-based and one picture-based. These conversation aids facilitated more shared decision-making and improved the decision process, among other outcomes, across four health systems with socioeconomically diverse patient populations. We conducted semi-structured interviews with a purposive sample of patient participants across conversation aid assignment and socioeconomic status (SES) and collected observations and field notes. We interviewed trial surgeons and other stakeholders. Two independent coders conducted framework analysis using the NOrmalization MeAsure Development through Normalization Process Theory. We also conducted an inductive analysis. We conducted additional sub-analyses based on conversation aid assignment and patient SES. Results We conducted 73 semi-structured interviews with 43 patients, 16 surgeons, and 14 stakeholders like nurses, cancer center directors, and electronic health record (EHR) experts. Patients and surgeons felt the conversation aids should be used in breast cancer care in the future and were open to various methods of giving and receiving the conversation aid (EHR, email, patient portal, before consultation). Patients of higher SES were more likely to note the conversation aids influenced their treatment discussion, while patients of lower SES noted more influence on their decision-making. Intervention surgeons reported using the conversation aids did not lengthen their typical consultation time. Most intervention surgeons felt using the conversation aids enhanced their usual care after using it a few times, and most patients felt it appeared part of their normal routine. Conclusions Key factors that will guide the future sustained implementation of the conversation aids include adapting to existing clinical workflows, flexibility of use, patient characteristics, and communication preferences. Trial registration ClinicalTrials.gov Identifier: NCT03136367, registered on May 2, 2017

BACKGROUND: The interest in shared decision making (SDM) and the use of patient decision aids has increased significantly. Research indicates that this approach has benefits and yet, implementation remains a challenge. To illustrate this development, we focus on vaccine hesitancy which has become a serious public health challenge during the COVID-19 pandemic. Various strategies have been used in healthcare, with limited success, to help patients overcome vaccine hesitancy. It is unclear whether SDM interventions can increase vaccination rates. AIMS: Our aim was twofold: to provide an overview of SDM and the use of patient decision aids, and to determine the effect of SDM interventions on vaccine uptake. METHODS: To provide an overview, we drew on our knowledge of the field and summarized the most recent systematic reviews. We examined the impact on vaccine hesitancy by searching for randomized controlled trials (RCTs) of SDM interventions, conducted a meta-analysis and calculated a pooled odds ratio. Additional outcomes were reported in a narrative synthesis. RESULTS: SDM is viewed as the pinnacle of patient centered care, supported by an ethical imperative and by empirical evidence of benefits. We found 10 RCTs that met our inclusion criteria. SDM interventions significantly increased vaccine uptake compared to control groups (OR=1.45; 95% CI 1.17, 1.80; p

There are numerous opportunities for shared decision-making (SDM) in cystic fibrosis (CF) care, yet little is known about patients’ SDM experiences. This study evaluated SDM across 159 CF care programs (4024 participants) in the United States. Shared decision-making was assessed using the patient-reported collaboRATE measure, which was included in the CF Foundation’s Patient and Family Experience of Care Survey over 18 months. Overall, 69% of respondents reported experiencing SDM. Respondents at pediatric programs were more likely to experience SDM than those at adult programs (72% vs 67%, P < .001). Multivariable logistic regression analyses showed a relationship between SDM and patient age, whereby SDM was less likely to occur with patients aged 18 to 24 years, compared to some younger and older age groups ( P = .02

The COVID-19 pandemic continues to affect millions of people worldwide. While hygiene, behavioural measures and government-driven restrictions are in place, a globally implemented vaccination programme shows promise at mitigating the levels of illness and mortality caused by the virus.1 The exceptional magnitude of the pandemic, combined with the unprecedented speed of vaccine development has caused difficulty ensuring that information is neutral, standardised, coherent and evidence-based.2 As a result, misinformation about the virus and the COVID-19 vaccine, often combined with conspiracy theories, has become a major threat to uptake.3–5 A recent study about COVID-19 misinformation in national samples across five countries showed that misinformation negatively affected people’s self-reported compliance with public health recommendations and reduced people’s willingness to get vaccinated and recommend the vaccine to others.3 Misinformation increases vaccine hesitancy and threatens cooperation with vaccination programmes. Vaccine hesitancy designates the ‘delay in acceptance or refusal of vaccines despite availability of vaccination services’.6 Ensuring easy access to high quality evidence-based information about the potential harms and benefits of vaccination would increase knowledge. This in turn could help create better dialogue with healthcare professionals, minimise vaccine hesitancy and promote informed choice. ### Potential of shared decision making Shared decision making is an approach where health professionals, patients and caregivers share available evidence-based information while exploring the patient’s values and priorities to achieve informed preferences.7 It typically includes three elements: providing information, supporting deliberation and exploring patient preferences to form an informed choice.7 8 This process may or may not be supported by a patient decision aid; a patient-facing, evidence-based intervention proven to improve decision …

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.

Background Some researchers argue that the successful implementation of patient decision aids (PDAs) into clinical workflows depends on their integration into electronic health records (EHRs). Anecdotally, we know that EHR integration is a complex and time-consuming task; yet, the process has not been examined in detail. As part of an implementation project, we examined the work involved in integrating an encounter PDA for symptomatic uterine fibroids into Epic EHR systems. Objective This study aims to identify the steps and time required to integrate a PDA into the Epic EHR system and examine facilitators and barriers to the integration effort. Methods We conducted a case study at 5 academic medical centers in the United States. A clinical champion at each institution liaised with their Epic EHR team to initiate the integration of the uterine fibroid Option Grid PDAs into clinician-facing menus. We scheduled regular meetings with the Epic software analysts and an expert Epic technologist to discuss how best to integrate the tools into Epic for use by clinicians with patients. The meetings were then recorded and transcribed. Two researchers independently coded the transcripts and field notes before categorizing the codes and conducting a thematic analysis to identify the facilitators and barriers to EHR integration. The steps were reviewed and edited by an Epic technologist to ensure their accuracy. Results Integrating the uterine fibroid Option Grid PDA into clinician-facing menus required an 18-month timeline and a 6-step process, as follows: task priority negotiation with Epic software teams, security risk assessment, technical review, Epic configuration; troubleshooting, and launch. The key facilitators of the process were the clinical champions who advocated for integration at the institutional level and the presence of an experienced technologist who guided Epic software analysts during the build. Another facilitator was the use of an emerging industry standard app platform (Health Level 7 Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources) as a means of integrating the Option Grid into existing systems. This standard platform enabled clinicians to access the tools by using single sign-on credentials and prevented protected health information from leaving the EHR. Key barriers were the lack of control over the Option Grid product developed by EBSCO (Elton B Stephens Company) Health; the periodic Epic upgrades that can result in a pause on new software configurations; and the unforeseen software problems with Option Grid (ie, inability to print the PDA), which delayed the launch of the PDA. Conclusions The integration of PDAs into the Epic EHR system requires a 6-step process and an 18-month timeline. The process required support and prioritization from a clinical champion, guidance from an experienced technologist, and a willing EHR software developer team.

Item does not contain fulltext OBJECTIVE: Assess the effect of pictorial health information on patients' and consumers' health behaviors and outcomes, evaluate these effects in lower health literacy populations, and examine the attributes of the interventions. METHODS: We included randomized controlled trials (RCTs) that assessed the effect of pictorial health information on patient and consumer health behaviors and outcomes. We conducted a meta-analysis of RCTs that assessed knowledge/understanding, recall, or adherence, and a subgroup analysis of those outcomes on lower health literacy populations. We narratively reviewed characteristics of pictorial health interventions that significantly improved outcomes for lower health literacy populations. RESULTS: From 4160 records, we included 54 RCTs (42 in meta-analysis). Pictorial health information moderately improved knowledge/understanding and recall overall, but largely increased knowledge/understanding for lower health literacy populations (n = 13), all with substantial heterogeneity. Icons with few words may be most helpful in conveying health information. CONCLUSION: Our results support including pictures in health communication to improve patient knowledge. Our results should be interpreted with caution considering the significant heterogeneity of the meta-analysis outcomes. PRACTICE IMPLICATIONS: Future research should assess which types and characteristics of pictures that best convey health information and are most useful and the implementation and sustainability in healthcare contexts. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018084743.

Background Implementing patient decision aids in clinic workflow has proven to be a challenge for healthcare organizations and physicians. Our aim was to determine the organizational strategies, motivations, and facilitating factors to the routine implementation of Option Grid™ encounter decision aids at two independent settings. Method Case studies conducted by semi-structured interview, using the Normalization Process Theory (NPT) as a framework for thematic analysis. Twenty three interviews with physicians, nurses, hospital staff and stakeholders were conducted at: 1) CapitalCare Medical Group in Albany, New York; 2) HealthPartners Clinics in Minneapolis, Minnesota. Results ‘Coherent’ motivations were guided by financial incentives at CapitalCare, and by a ‘champion’ physician at HealthPartners. Nurses worked ‘collectively’ at both settings and played an important role at sites where successful implementation occurred. Some physicians did not understand the perceived utility of Option Grid™, which led to varying degrees of implementation success across sites. The appraisal work (reflexive monitoring) identified benefits, particularly in terms of information provision. Physicians at both settings, however, were concerned with time pressures and the suitability of the tool for patients with low levels of health literacy. Conclusion Although both practice settings illustrated the mechanisms of normalization postulated by the theory, the extent to which Option Grid™ was routinely embedded in clinic workflow varied between sites, and between clinicians. Implementation of new interventions will require attention to an identified rationale (coherence), and to the collective action, cognitive participation, and assessment of value by organizational members of the organization. Electronic supplementary material The online version of this article (doi:10.1186/s12911-017-0517-2) contains supplementary material, which is available to authorized users.

Objective To user-test graphical display formats (icon arrays, pie, bar, and line charts) to identify preferred formats and metrics (‘probability of death or stroke’ or ‘proportion of time lived without death or stroke’) in order to display time-dependent risks of stroke or death for three carotid stenosis treatments: endarterectomy (surgery), stenting, and medical therapy. Methods Iterative cycles of semi-structured interviews with patients recruited from a Vascular Clinic. Results A total of 27 patients (mean age = 68; range: 50–85) were interviewed over four cycles. Patients strongly preferred the pie chart over icon arrays, and over bar or line graphs. The preference was based on patient recognition of the time-based increase in risk for stroke or death for treatment options. Patients preferred data presented as probabilities instead of the proportion of time lived. We did not assess patients’ understanding. Conclusion Patients preferred the pie chart formats and reported better realization that risks increase with time for each option and that tradeoffs exist when surgery has a higher short-term risk than medical therapy. Practice implications There remains debate on how best to convey time-dependent risk information to patients, especially where low literacy and numeracy might exist.

Context No brief patient-reported experience measure focuses on the most significant concerns of seriously ill individuals. Objectives The objective of the study was to develop the consideRATE questions. Methods This user-centered design study had three phases. We reviewed the literature and consulted stakeholders, including caregivers, clinicians, and researchers, to identify the elements of care most important to patients (Phase 1). We refined items based on cognitive interviews with patients, families, and clinicians (Phase 2). We piloted the measure with patients and families (Phase 3). Results Phase 1 resulted in seven questions addressing the following elements: 1) care team attention to patients' physical symptoms, 2) emotional symptoms, 3) environment of care, 4) respect for patients' priorities, 5) communication about future plans, 6) communication about financial and similar affairs, and 7) communication about illness trajectory. Phase 2 participants included eight patients, eight family members, and seven clinicians. We added an open-text comment option. We did not identify any other issues that were important enough to participants to include. Response choices ranged from one (very bad) to four (very good), with a not applicable option (does not apply). Phase 3 involved 15 patients and 16 family members and demonstrated the acceptability of the consideRATE questions. Most reported that the questions were not distressing, disruptive, or confusing. Completion time averaged 2.4 minutes (range 1–5). Conclusion Our brief patient-reported serious illness experience measure is based on what matters most to patients, families, and clinicians. It was acceptable to patients and families in a regional sample. It has promise for use in clinical settings.

Background True allergy to penicillin is rare, despite the high frequency with which it is reported. While most patients reporting penicillin allergy are not prone to anaphylaxis, it is not currently known what percentage of these patients will tolerate dose challenges of penicillin-based antibiotics. This review aims to determine the rate of tolerance in patients reporting penicillin allergy when challenged with penicillin-based antibiotics. Methods We searched MedLine, Embase, and Cochrane Library for publications with English language translations between the years 2000 and 2017. We included randomized controlled trials, quasi-experimental, and observational studies of participants reporting penicillin allergy who received at least one systemic dose of a penicillin in the form of a drug challenge. At least 2 independent reviewers extracted data from included studies and assessed the quality of each included study. To generate primary outcome data, we calculated a summary estimate rate of penicillin tolerance from a pooled proportion of participants receiving penicillin with no adverse effects. Results Initial literature search yielded 2945 studies, of which 23 studies were ultimately included in our review; 5056 study participants with reported history of penicillin allergy were challenged with a penicillin. After weighting for study sample size, a pooled average of 94.4% (95% confidence interval, 93.7%-95%) of participants tolerated the dose challenge without any adverse reaction. Conclusion Misrepresented penicillin allergy drives unnecessary use of alternative antibiotics, which may be less effective, more toxic, and more expensive than using penicillin. In addressing the problem of penicillin allergy over-diagnosis, evaluation should go beyond risk for type 1 hypersensitivity. Our data suggest that 94.4% of 5056 participants with reported penicillin allergy determined to be clinically appropriate for allergy evaluation tolerated repeat administration of penicillin-based antibiotics without any adverse reactions. This review generates meaningful information useful to clinical predictive analytics, in evaluating and managing patients with a reported history of penicillin allergy.

Introduction. Breast cancer is the second most common malignancy in women. The Decision Quality Instrument (DQI) measures the extent to which patients are informed and involved in breast surgery decisions and receive treatment that aligns with their preferences. There are limited data on the performance of the DQI in women of lower socioeconomic status (SES). Our aims were to 1) examine (and if necessary adapt) the readability, usability, and acceptability of the DQI and 2) explore whether it captures factors important to breast cancer surgery decisions among women of lower SES (relevance). Methods. We conducted semistructured cognitive interviews with women of lower SES (based on insurance status, income, and education) who had completed early-stage breast cancer treatments at three cancer centers. We used a two-step thematic analysis with dual independent coding. The study team (including Patient Partners and a Community Advisory Board) reviewed and refined suggested changes. The revised DQI was presented in two focus groups of breast cancer survivors. Results. We conducted 39 interviews. Participants found most parts of the DQI to be helpful and easy to understand. We made the following suggested changes: 1) added a glossary of key terms, 2) added two answer choices and an open text question in the goals and concerns subscale, 3) reworded the treatment intention question, and 4) revised the knowledge subscale instructions since several women disliked the wording and were unsure of what was expected. Discussion. The readability, usability, acceptability, and relevance of a measure that was primarily developed and validated in women of higher SES required adaptation for optimal use by women of lower SES. Further research will test these adaptations in lower SES populations.

IntroductionMost health information is verbal or written, yet words alone may not be the most effective way to communicate health information. Lower health literacy is prevalent in the US and is linked to limited understanding of one’s medical condition and treatment. Pictures increase comprehension, recall, adherence and attention in health settings. This is called pictorial superiority. No systematic review has examined the impact of pictorial health information among patients and consumers, including those with lower health literacy.Methods and analysisThis systematic review and meta-analysis will assess the characteristics and effectiveness of pictorial health information on patient and consumer health behaviours and outcomes, as well as differentially among individuals of lower literacy/lower health literacy. We will conduct a systematic search across selected databases, as well as grey literature, from inception until June 2018. We will include randomised controlled trials in all languages with all types of participants that assess the effect of pictorial health information on patients’ and consumers’ health behaviours and outcomes. Two independent reviewers will conduct the primary screening of articles and data extraction for the selected articles with a third individual available to resolve conflicts. We will assess the quality of all included studies using the Cochrane risk of bias tool. We will combine all selected studies and do a test of heterogeneity. If there is sufficient homogeneity, we will pool studies into a meta-analysis. Independent of the heterogeneity of included studies, we will also conduct a narrative synthesis.Ethics and disseminationNo ethics approval is required. The results will be published in a peer-reviewed journal and presented at relevant conferences.PROSPERO registration numberCRD42018084743.

Background. Randomized trials have shown that patient decision aids can modify users’ preferred healthcare options, but research has yet to identify the attributes embedded in these tools that cause preferences to shift. Objectives. The aim of this study was to investigate people’s preferences as they used decision aids for 5 health decisions and, for each of the following: 1) determine if using the interactive Option Grid led to a pre–post shift in preferences; 2) determine which frequently asked questions (FAQs) led to preference shifts; 3) determine the FAQs that were rated as the most important as users compared options. Methods. Interactive Option Grid decision aids enable users to view attributes of available treatment or screening options, rate their importance, and specify their preferred options before and after decision aid use. The McNemar–Bowker paired test was used to compare stated pre–post preferences. Multinomial logistic regressions were conducted to investigate possible associations between covariates and preference shifts. Results. Overall, 626 users completed the 5 most-used tools: 1) Amniocentesis test: yes or no? ( n = 73); 2) Angina: treatment options ( n = 88); 3) Breast cancer: surgical options ( n = 265); 4) Prostate Specific Antigen (PSA) test: yes or no? ( n = 82); 5) Statins for heart disease risk: yes or no? ( n = 118). The breast cancer, PSA, and statins Option Grid decision aids generated significant preference shifts. Generally, users shifted their preference when presented with the description of the available treatment options, and the risk associated with each option. Conclusion. The use of decision aids for some, but not all health decisions, was accompanied by a shift in user preferences. Users typically valued information associated with risks, and chose more risk averse options after completing the interactive tool.

Background Research on the implementation of patient decision aids to facilitate shared decision making in clinical settings has steadily increased across Western countries. A study which implements decision aids and measures their impact on shared decision making has yet to be conducted in the Eastern part of Europe. Objective To study the use of Option GridTM patient decision aids in a sample of Grupa LUX MED clinics in Warsaw, Poland, and measure their impact on shared decision making. Method We conducted a pre-post interventional study. Following a three-month period of usual care, clinicians from three Grupa LUX MED clinics received a one-hour training session on how to use three Option GridTM decision aids and were provided with copies for use for four months. Throughout the study, all eligible patients were asked to complete the three-item CollaboRATE patient-reported measure of shared decision making after their clinical encounter. CollaboRATE enables patients to assess the efforts clinicians make to: (i) inform them about their health issues; (ii) listen to ‘what matters most’; (iii) integrate their treatment preference in future plans. A hierarchical logistic regression model was performed to understand which variables had an effect on CollaboRATE. Results 2,048 patients participated in the baseline phase; 1,889 patients participated in the intervention phase. Five of the thirteen study clinicians had a statistically significant increase in their CollaboRATE scores (p Conclusion The implementation of Option GridTM helped some clinicians practice shared decision making as reflected in CollaboRATE scores, but most clinicians did not have a significant increase in their scores. Our study indicates that the effect of these interventions may be dependent on clinic contexts and clinician engagement.

Contains fulltext : 174289.pdf (Publisher’s version ) (Open Access) INTRODUCTION: Shared decision making (SDM) is a goal of modern medicine; however, it is not currently embedded in routine care. Barriers include cliniciansaeuro attitudes, lack of knowledge and training and time constraints. Our goal is to support the development and delivery of a robust SDM curriculum in medical education. Our objective is to assess undergraduate medical studentsaeuro knowledge of and attitudes towards SDM in four countries. METHODS AND ANALYSIS: The first phase of the study involves a web-based cross-sectional survey of undergraduate medical students from all years in selected schools across the United States (US), Canada and undergraduate and graduate students in the Netherlands. In the United Kingdom (UK), the survey will be circulated to all medical schools through the UK Medical School Council. We will sample students equally in all years of training and assess attitudes towards SDM, knowledge of SDM and participation in related training. Medical students of ages 18 years and older in the four countries will be eligible. The second phase of the study will involve semistructured interviews with a subset of students from phase 1 and a convenience sample of medical school curriculum experts or stakeholders. Data will be analysed using multivariable analysis in phase 1 and thematic content analysis in phase 2. Method, data source and investigator triangulation will be performed. Online survey data will be reported according to the Checklist for Reporting the Results of Internet E-Surveys. We will use the COnsolidated criteria for REporting Qualitative research for all qualitative data. ETHICS AND DISSEMINATION: The study has been approved for dissemination in the US, the Netherlands, Canada and the UK. The study is voluntary with an informed consent process. The results will be published in a peer-reviewed journal and will help inform the inclusion of SDM-specific curriculum in medical education worldwide.

The aim of this paper is to update the previous review on the state of patient and public participation in healthcare in Italy. Policymakers consider patient involvement an important aspect in health care decisions and encourage patients to actively participate in the clinical interaction. Nevertheless, the term shared decision making (SDM) is still not clearly defined. Patient associations promote patient participation in health care decisions. Several experts attended the latest consensus conference about patient engagement to reach a consensus on the definition of SDM. Research regarding SDM in Italy continues to increase with 17 articles published between 2012 and 2017. Researchers have assessed the variables associated with patient involvement and explored the use of the SDM approach in different medical settings. Despite the dedicated SDM initiative, researchers in Italy recognize room for improvement. Work is needed to reach a common language regarding SDM and its mechanisms to implement this approach at the clinical level.

ObjectivesOur aim was to conduct a systematic review of the literature to determine the impact of patient decision aids (PDA) on patients facing treatment decisions for colorectal cancer.DesignSystematic review.Data sourcesSources included Embase, Medline, Web of Science, CINAHL and the Cochrane Library from inception to June, 20, 2019.Eligibility criteriaWe included randomised controlled trials (RCTs), cohort studies, mixed methods and case series in which a PDA for colorectal cancer treatment was used. Qualitative studies were excluded from our review.Data extraction and synthesisFollowing execution of the search strategy by a medical librarian, two blinded independent reviewers identified articles for inclusion. Two blinded reviewers were also responsible for data extraction, risk of bias and study quality assessments. Any conflict in article inclusion or extraction was resolved by discussion.ResultsOut of 3773 articles identified, three met our inclusion criteria: one RCT, one before-and-after study and one mixed-method study. In these studies, the use of a PDA for colorectal cancer treatment was associated with increased patient knowledge, satisfaction and preparation for making a decision. On quality assessment, two of three studies were judged to be of low quality.ConclusionA paucity of evidence exists on the effect of PDA for colorectal cancer treatment with existing evidence being largely of low quality. Further investigation is required to determine the effect of decision aids for colorectal cancer treatment as well as reasons for the lack of PDA development and implementation in this area.Prospero registration numberCRD42018095153.

ObjectiveTo user-test a web-based, interactive Option Grid decision aid ‘prostate-specific antigen (PSA) test: yes or no?’ to determine its usability, acceptability and feasibility with men of high and low health literacy.DesignA semi-structured interview study.SettingInterviews were conducted at a senior centre, academic hospital or college library in New Hampshire and Vermont.ParticipantsIndividuals over 45 years of age with no history of prostate cancer who voluntarily contacted study authors after viewing local invitations were eligible for inclusion. Twenty interviews were conducted: 10 participants had not completed a college degree, of which eight had low health literacy, and 10 participants had high health literacy.InterventionAn interactive, web-based Option Grid patient decision aid for considering whether or not to have a PSA test.ResultsUsers with lower health literacy levels were able to understand the content in the tool but were not able to navigate the Option Grid independent of assistance. The tool was used independently by men with high health literacy. In terms of acceptability, the flow of questions and answers embedded in the tool did not seem intuitive to some users who preferred seeing more risk information related to age and family history. Users envisioned that the tool could be feasibly implemented in clinical workflows.ConclusionMen in our sample with limited health literacy had difficulty navigating the Option Grid, thus suggesting that the tool was not appropriately designed to be usable by all audiences. The information provided in the tool is acceptable, but users preferred to view personalised risk information. Some participants could envision using this tool prior to an encounter in order to facilitate a better dialogue with their clinician.Ethics approvalThe study received ethical approval from the Dartmouth College Committee for the Protection of Human Subjects (STUDY00030116).

Background True allergy to penicillin is rare, despite the high frequency with which it is reported. Misrepresented allergy drives unnecessary use of alternative antibiotics which may be less effective, more toxic, and more expensive than the penicillins. While most patients reporting penicillin allergy are not prone to anaphylaxis, it is not currently known what percentage of these patients go on to fully tolerate systemic doses of penicillin-based antibiotics. This review aims to determine the tolerance rate in patients with non-anaphylactic penicillin allergy when challenged with systemic doses of penicillin-based antibiotics. Methods We searched MedLine, Embase, and Cochrane Library for publications with English language translations between the years 2000 and 2017. We included controlled trials, quasi-experimental, and observational studies of reportedly penicillin-allergic subjects who received at least one systemic dose of a penicillin in the form of a challenge. At least two independent reviewers extracted data from included studies, and assessed the quality of each included study. To generate primary outcome data, we calculated a summary estimate rate of penicillin tolerance from a pooled fraction of subjects receiving a penicillin with no adverse effects, among all subjects receiving a penicillin challenge. Results Initial literature search yielded 5,554 studies, of which 22 studies were ultimately included in our review. A total of 4,572 study participants, each with a history of penicillin allergy low risk for anaphylaxis, were challenged with systemic dosing of a penicillin. After weighting for sample size, an average of 94.8% [95% CI 93.3%, 96.3%] of these patients tolerated penicillin challenge without any adverse reaction. Conclusion In addressing the problem of penicillin allergy over-diagnosis, evaluation should go beyond risk for type 1 hypersensitivity. Our data suggest that 94.8% of 4,572 subjects with reported penicillin allergy determined to be low risk for anaphylaxis tolerated repeat administration of penicillin-based antibiotics without any adverse reactions. This review generates meaningful information useful to clinical predictive analytics, in evaluating and managing patients with a reported history of penicillin allergy. Disclosures All authors: No reported disclosures.